Pleo Not (Terra-Medica) – penicillin contamination (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.
Brand
Terra-Medica Inc.
Lot Codes / Batch Numbers
(10 x 1mL): Batch # 07099, EXP: August 2014, Batch # 15090, EXP: August 2015, Batch # 06120, EXP: November 2015, Batch #19023, EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014, Batch # 15090, EXP: August 2015, Batch # 1110, EXP: October 2015, Batch #6120, EXP: November 2015, Batch # 19023, EXP January 2018.
Products Sold
(10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018.
Terra-Medica Inc. is recalling Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, due to Penicillin Cross Contamination. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Penicillin Cross Contamination
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026