B&B Pharmaceuticals Recalls Estradiol Powder Due to Foreign Material
B&B Pharmaceuticals is recalling Estradiol USP powder because Teflon was found in the product. The recall covers 3,825 grams distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The presence of Teflon is a foreign material contamination, but no specific injuries or illnesses are reported in the source text, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
B&B Pharmaceuticals, Inc. is recalling Estradiol, USP (Non-Micronized) (Hemihydrate) powder. The product is packaged in 500-gram, 100-gram, and 25-gram containers. The recall involves a total of 3,825 grams of the product, which was distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, foreign material identified as Teflon was introduced at the production level. The affected lot number is 18K26-BB02-PR00553, with a reassay date of 10/09/2023. The product numbers involved are 700365, 700362, and 700363.
Consumers and healthcare providers should check their inventory for the specific lot number and NDC codes listed in the recall notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations. B&B Pharmaceuticals can be contacted at 800-499-3100 for further information.
The recalled product
- Product
- Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
- Manufacturer
- B & B Pharmaceuticals, Inc.
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 18K26-BB02-PR00553
- Reassay 10/09/2023 Product # 700365
- 700362 & 700363
Distribution
Distributed nationwide across the United States.
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